BIP_UCB EP0092

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects with Drug-Resistant Epilepsy

Key Inclusion Criteria:
-Diagnosis of focal epilepsy per 1989 International League Against Epilepsy (ILAE) criteria at least 3 years before study entry
-Subject has failed to achieve seizure control with >= 4 tolerated and appropriately choisen prior antiepileptic drugs (AED), including past and ongoing treatment
-Average of <= 4 spontaneous and observable focal seizures (i.e. focal aware, focal impaired awareness and focal to bilateral tonic-clonic) per month
-Current treatment with a stable dose of at least 1 and up to 3 AEDs for the 8 weeks prior to the Screening Visit

Key Exclusion Criteria:
-Subject has a history of or signs of generalized or combined generalized and focal epilepsy
-Cluster seizures with are uncountable in the previous 8 weeks before study entry
-Current treatment with carbamazepine, phenytoin, primidone, phenobarbital

**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
Phase III
NCT03739840
Neurosciences
Epilepsy
Evan Fertig, M.D.
UCB Pharmaceutical
Hannah Voss
  • Providence Portland Medical Center
  • Providence St. Vincent Medical Center